FDA 510(k)

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee

Número K: K222056 · 2023-01-26

RequerenteHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Data da decisão2023-01-26

Código do produtoJDI

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2023-01-26 under 510(k) number K222056. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee?

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee is a medical device that received FDA 510(k) clearance on 2023-01-26. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K222056.

When did Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee receive FDA 510(k) clearance?

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee received FDA 510(k) clearance on 2023-01-26, under 510(k) number K222056.

Who is the listed applicant for Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee?

The FDA 510(k) record lists Howmedica Osteonics Corp., Dba Stryker Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee?

The FDA product code for Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee is JDI.

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Outros registros que listam Howmedica Osteonics Corp., Dba Stryker Orthopaedics como candidato(a)

K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper K252044Triathlon® Total Knee System - Triathlon® Gold Femoral Components K251665Triathlon® Hinge Knee System

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Fonte oficial

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